scholarly journals Extended-Release and Long-Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS):

2017 ◽  
Vol 103 (4) ◽  
pp. 7-16
Author(s):  
Daniel U. Rabin ◽  
Heather K. Tarbox ◽  
Lois Colburn ◽  
Kelly C. Alfred
Keyword(s):  
Health Care Providers ◽  
Risk Evaluation ◽  
Extended Release ◽  
Clinical Decision Making ◽  
Opioid Analgesics ◽  
The United States ◽  
Mitigation Strategy ◽  
Care Providers ◽  
Long Acting ◽  
The Impact

In response to the proliferation and abuse of opioids in the United States, the U.S. Food and Drug Administration (FDA) recently required manufacturers of extended-release and long-acting (ER/LA) opioid analgesics to provide education for prescribers of these medications through an FDA-approved risk management program. As a part of its Risk Evaluation and Mitigation Strategy (REMS), the FDA provided a blueprint for content to help accredited continuing medical education (CME) providers develop educational modules for prescribers. The University of Nebraska Medical Center (UNMC), the Federation of State Medical Boards (FSMB), the FSMB Foundation, The France Foundation, and CECity worked collaboratively to create “Extended-Release and Long-Acting Opioid Analgesics,” a prescriber education program aligned with the FDA blueprint, comprised of live meetings and web-based enduring activities that spanned April 2014 to February 2016. A total of 4,535 health care providers participated in the live and enduring REMS CME activities and completed evaluations of these activities. The evaluations were analyzed to learn more about the impact of the content on prescribers' knowledge and clinical decision-making. Results were similar for live and enduring activities. Participant-knowledge increased by 22 percentage points. Several competence measures suggest that learners returned to practice with more confidence, and 83% declared specific practice changes they planned to make to improve patient assessment and care. More than one-third of the evaluation respondents felt there were no barriers to making intended practice changes. More than 95% of the respondents said the activity increased their ability to apply knowledge, skills, and judgment in practice. Analysis suggests that live and enduring educational activities, following the FDA REMS blueprint, can impact prescriber attitudes and future care-decisions related to ER/LA opioid analgesics. These results justify additional efforts to involve more participants in these REM activities.

scholarly journals Changes in Mortality Involving Extended-Release and Long-Acting Opioids After Implementation of a Risk Evaluation and Mitigation Strategy

Pain Medicine ◽  
2019 ◽  
Vol 21 (1) ◽  
pp. 92-100 ◽  
Author(s):  
Joshua C Black ◽  
Gabrielle E Bau ◽  
Travis Rosen ◽  
M Soledad Cepeda ◽  
Gregory P Wedin ◽  
...  
Keyword(s):  
Mortality Rate ◽  
Risk Evaluation ◽  
Extended Release ◽  
Opioid Analgesic ◽  
Opioid Analgesics ◽  
Mortality Rates ◽  
Mitigation Strategy ◽  
Medical Examiner ◽  
Significant Heterogeneity ◽  
Long Acting

Abstract Objective To assess changes in mortality rates in extended-release and long-acting (ER/LA) opioid analgesics after the implementation of the Risk Evaluation and Mitigation Strategy (REMS). Setting All drug poisoning deaths in three states: Florida, Oregon, and Washington. Data were obtained through state vital records offices and the Researched Abuse, Diversion and Addiction-Related Surveillance System Medical Examiner Program. Methods Using cause-of-death literal text from death certificates, individual opioid active pharmaceutical ingredients (APIs) involved in each death were identified using rules-based natural language processing. Population-adjusted and prescriptions dispensed–adjusted mortality rates were calculated for all ER/LA opioid analgesic and individual opioid APIs. Rates before and after implementation of the REMS were compared. Rate changes were compared with rates from two APIs with little or no inclusion in the REMS: benzodiazepines and hydrocodone. Results The mean ER/LA opioid analgesic population-adjusted mortality rate significantly decreased in all three states (FL: P = 0.003; OR: P = 0.003; WA: P < 0.001). Mortality rates for benzodiazepines and hydrocodone also decreased and were not statistically different. Significant heterogeneity in mortality rates of individual opioids was observed between the three states. When adjusted for prescription volume, the ER/LA opioid analgesic mortality rate decreased in all three states, but was significant only for Washington (P < 0.001). Conclusions The population-adjusted mortality rate of ER/LA opioid analgesics has decreased in three states. Notably, the contributions to mortality rates by individual opioid analgesics were not uniform across the three states in this study. However, these changes were not generally distinct from changes in mortality rates where comparator substances were involved.

Assessing the impact of the extended-release/long-acting opioid analgesics risk evaluation and mitigation strategies on opioid prescription volume

2017 ◽  
Vol 13 (3) ◽  
pp. 157 ◽  
Author(s):  
Victoria Divino, BA ◽  
M. Soledad Cepeda, MD, PhD ◽  
Paul Coplan, ScD, MBA, MPH ◽  
Jean-Yves Maziere, MD, PhD ◽  
Yingli Yuan, PhD ◽  
...  
Keyword(s):  
Risk Evaluation ◽  
Extended Release ◽  
Opioid Analgesic ◽  
Opioid Analgesics ◽  
Patient Characteristics ◽  
Mitigation Strategies ◽  
Opioid Prescription ◽  
Long Acting ◽  
The Impact ◽  
Prescription Volume

Objective: The Food and Drug Administration approved the extended-release/long-acting (ER/LA) opioid analgesics risk evaluation and mitigation strategies (REMS) in July 2012 to educate healthcare providers and patients about safe and appropriate opioid analgesic use. The authors evaluated the impact of the REMS on ER/LA opioid analgesic utilization, overall and stratified by patient characteristics and prescriber type associated with greater expected need for analgesia. Design: Retrospective repeated cross-sectional study. QuintilesIMS's National Prescription Audit™ and LifeLink™ patient-level longitudinal prescription databases measured prescription volumes, projected to national estimates.Main Outcome Measures: Changes were assessed in ER/LA opioid analgesic prescriptions dispensed from the 2-year pre-REMS implementation (July 2010 to June 2012) to the 18-month post-REMS implementation (July 2013 to December 2014) periods (with 12-month transitional implementation period in between).Results: Average quarterly ER/LA opioid prescription volume significantly decreased by 4.3 percent from Preimplementation to the Active Period (5.58 vs 5.34 million, p < 0.001). Differences in prescription volume change were observed between age, gender, and payer types. Prescription volume either significantly decreased or remained stable from Preimplementation to the Active Period among most provider specialties evaluated. The largest volume decreases were observed for dentists (–48.5 percent) and emergency medicine specialists (–25.5 percent) (both p < 0.001). The largest increases were observed for nurse practitioners (+33.7 percent) and physician assistants (+31.2 percent; both p < 0.001), whose overall prescribing of nonopioid medications also increased. Conclusions: A significant decrease in dispensed ER/LA opioid prescriptions was observed following REMS implementation compared to Preimplementation. The impact on volume varied by patient characteristics and prescriber specialty. The REMS program, in conjunction with other healthcare policies and initiatives, likely influenced these observations.

Searching and Making Meaning of the COVID-19 Pandemic: Perspectives of African Immigrants in the United States

2021 ◽  
pp. 002216782110224
Author(s):  
Angela U. Ekwonye ◽  
Nina Truong
Keyword(s):  
United States ◽  
Health Care Providers ◽  
Meaning Making ◽  
Democratic Republic Of Congo ◽  
Central Africa ◽  
African Immigrants ◽  
The United States ◽  
Care Providers ◽  
Making Meaning ◽  
The Impact

African immigrants continue to be disproportionately affected by the COVID-19 pandemic. It is unclear how they are searching for and finding meaning in the face of this adversity. This study sought to understand how African immigrants in the United States are searching for and making meaning of the COVID-19 pandemic. We conducted in-depth interviews remotely with 20 immigrants from West Africa (Nigeria and Ghana), East Africa (Somali and Rwanda), and Central Africa (Democratic Republic of Congo). The meaning-making model was used as a framework to understand the processes of coping during a significant, adverse life event. The study found that some participants attempted to reduce the impact of the COVID-19 pandemic on their global meaning by seeking answers as to why the pandemic occurred and creating positive illusions. Some redefined their priorities and reframed the pandemic in a positive light. Participants found meaning in the form of accepting the pandemic as a reality of life, appreciating events previously taken for granted, and making positive changes in their lives. This study’s findings can inform health care providers of the meaning-making processes of African immigrants’ and the need to assist them in their search for meaning.

US Food and Drug Administrationʼs Risk Evaluation and Mitigation Strategy for Extended-Release and Long-Acting Opioids

Drugs ◽  
2012 ◽  
Vol 72 (18) ◽  
pp. 2327-2332 ◽  
Author(s):  
Sebastiano Mercadante ◽  
David Craig ◽  
Antonello Giarratano
Keyword(s):  
Risk Evaluation ◽  
Extended Release ◽  
Mitigation Strategy ◽  
Long Acting

scholarly journals The Affordable Care Act: Where Are We Now? An NCCN Roundtable

2014 ◽  
Vol 12 (5S) ◽  
pp. 745-747 ◽  
Author(s):  
Christian G. Downs ◽  
Liz Fowler ◽  
Michael Kolodziej ◽  
Lee H. Newcomer ◽  
Mohammed S. Ogaily ◽  
...  
Keyword(s):  
Health Care ◽  
Health Care Providers ◽  
Affordable Care Act ◽  
The United States ◽  
Annual Conference ◽  
Care Providers ◽  
Future Challenges ◽  
The Affordable Care Act ◽  
Oncology Practice ◽  
The Impact

The Affordable Care Act (ACA) is a transformational event for health care in the United States, with multiple impacts on health care, the economy, and society. Oncologists and other health care providers are already experiencing many changes—direct and indirect, anticipated and unanticipated. A distinguished and diverse panel assembled at the NCCN 19th Annual Conference to discuss the early phase of implementation of the ACA. The roundtable touched on early successes and stumbling blocks; the impact of the ACA on contemporary oncology practice and the new risk pool facing providers, payers, and patients; and some of the current and future challenges that lie ahead for all.

Problem and Pathological Gambling: A Consumer Perspective

CNS Spectrums ◽  
1998 ◽  
Vol 3 (6) ◽  
pp. 48-57 ◽  
Author(s):  
Laura M. Letson
Keyword(s):  
Health Care ◽  
Health Care Providers ◽  
Health Care Services ◽  
Public Awareness ◽  
The United States ◽  
Care Providers ◽  
Compulsive Gambling ◽  
Care Services ◽  
Consumer Perspective ◽  
The Impact

AbstractThe growth of gambling across the United States over the past decade has created significant difficulties for pathological gamblers. The rise in problem gambling, coupled with an increasing strain on social and health care services for treatment of gamblers and their families, has resulted in an urgent need for innovative interventions that target patients, health care providers, educational institutions, government, media, and the gambling industry. This article describes the impact of gambling from a consumer-protection perspective, and offers approaches to promoting public awareness of compulsive gambling as a pervasive problem that affects multiple areas of society.

scholarly journals Perspectives on the COVID-19 pandemic impact on cardio-oncology: results from the COVID-19 International Collaborative Network survey

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Diego Sadler ◽  
◽  
Jeanne M. DeCara ◽  
Joerg Herrmann ◽  
Anita Arnold ◽  
...  
Keyword(s):  
Health Care ◽  
Health Care Providers ◽  
Care Delivery ◽  
The United States ◽  
Medical Professional ◽  
Collaborative Network ◽  
Care Providers ◽  
Future Health ◽  
Professional Societies ◽  
The Impact

Abstract Background Re-allocation of resources during the COVID-19 pandemic has resulted in delays in care delivery to patients with cardiovascular disease and cancer. The ability of health care providers to provide optimal care in this setting has not been formally evaluated. Objectives To assess the impact of COVID-19 resource re-allocation on scheduling, testing, elective procedures, telemedicine access, use of new COVID-19 therapies, and providers’ opinions on healthcare policies among oncology and cardiology practitioners. Methods An electronic survey was conducted by a cardio-oncology collaborative network through regional and state chapters of the American College of Cardiology, American Society of Clinical Oncology, and the International Cardio-Oncology Society. Descriptive statistics were reported by frequency and proportion for analyses, and stratified categorically by geographic region and specialty. Results One thousand four hundred fifteen providers (43 countries) participated: 986 cardiologists, 306 oncologists, and 118 trainees/internal medicine. 63% (195/306) of oncologists vs 92% (896/976) of cardiologists reported cancellations of treatments/elective procedures (p = 0.01). 46% (442/970) of cardiologists and 25% (76/303) of oncologists modified the scope of their practice (p = < 0.001). Academic physicians (74.5%) felt better supplied with personal protective equipment (PPE) vs non-academic (74.5% vs 67.2%; p = 0.018). Telemedicine was less common in Europe 81% (74/91), and Latin America 64% (101/158), than the United States, 88% (950/1097) (p = < 0.001). 95% of all groups supported more active leadership from medical professional societies. Conclusions These results support initiatives to promote expanded coverage for telemedicine, increased access to PPE, better testing availability and involvement of medical professional societies to help with preparedness for future health care crisis.

Pharmacist’s Role in Dispensing Opioids for Acute and Chronic Pain

2011 ◽  
Vol 25 (5) ◽  
pp. 497-502 ◽  
Author(s):  
Karen F. Marlowe ◽  
Richard Geiler
Keyword(s):  
Health Care ◽  
Chronic Pain ◽  
Pain Management ◽  
Health Care Providers ◽  
Family Relationships ◽  
Health Care Professionals ◽  
The United States ◽  
Care Providers ◽  
Economic Productivity ◽  
The Impact

Pain continues to be a serious health care concern in the United States. Patients with chronic pain experience the impact of the disease throughout their lives including their social interactions, family relationships, and in many cases economic productivity. Multiple surveys have found that many pharmacists hold misconceptions regarding opioids, pain disease states, and their understandings of current regulations. Multiple barriers affect the ability of pharmacists to deliver care to patients' prescribed opioid therapy. Inadequate communication between health care professionals and patients is one of the hurdles, which prevents quality care. Increased communication between health care providers including access to health information is one step, which is crucial to improving provision of pharmacotherapy. Finally, the quality of educational opportunities relative to opioids and pain management specifically for pharmacists needs to be increased, and consideration needs to be given for making appropriate pain management education mandatory.

Implementation of School Diabetes Care in the United States: A Scoping Review

2021 ◽  
pp. 105984052110263
Author(s):  
Ruopeng An ◽  
Danyi Li ◽  
Marjorie Cole ◽  
Katherine Park ◽  
Aaron R. Lyon ◽  
...  
Keyword(s):  
Health Care Providers ◽  
Scoping Review ◽  
Diabetes Care ◽  
The United States ◽  
Local Health ◽  
Care Providers ◽  
Multiple Stakeholders ◽  
Complex Interactions ◽  
K 12 ◽  
The Impact

Diabetes management at school demands close collaboration of multiple stakeholders, including students with diabetes and parents, school nurses, teachers/staff, and local health care providers. This scoping review identified and synthesized evidence concerning factors that contributed to the quality and effectiveness of diabetes care implementation in U.S. K-12 schools. Forty-six studies met the eligibility criteria and were included. Five common factors emerged surrounding training and experiences, communications, parent engagement, resource allocations, and school environment. Complex interactions between multiple stakeholders jointly determined the quality of school diabetes care. A conceptual model was established to elucidate the complex interactions between multiple stakeholders and the relevant facilitators and barriers. Future research should improve sample representativeness, contrast school diabetes care practices to the national guidelines, and assess the impact of the social, economic, and political environment at federal, state, local/district levels on school diabetes care implementation.

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